MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-17 for IN-FAST ULTRA KIT 72403885 * manufactured by American Medical Systems.
[340814]
Vaginal sling procedure. A kit was received on sterile field with screw visibly not in correct placement in the inserter. The screw was reinserted into inserter before handling to the surgeon. The screw did not disengage upon firing and screw came out bent. The tip of inserter was cleaned and a new screw was loaded. Upon extraction of the inserter it was noticed that the clear plastic end of the inserter had fallen off inside the pt. The foreign body was removed and a new kit opened which fired without incident. Device usage problem: device malfunction-that is, the device did not do what it was supposed to do.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 505789 |
| MDR Report Key | 505789 |
| Date Received | 2003-10-17 |
| Date of Report | 2003-10-01 |
| Date Added to Maude | 2004-01-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IN-FAST ULTRA KIT |
| Generic Name | VAGINAL SLING |
| Product Code | FHK |
| Date Received | 2003-10-17 |
| Model Number | 72403885 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 376185 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 494656 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Manufacturer Address | 10700 BREN RD WEST MINNETONKA MN 55343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-17 |